Food Exposure Therapy in Anorexia Nervosa
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Purpose
This is a research study to determine whether a medication called D-cycloserine (DCS) in combination with a type of psychotherapy called Exposure Therapy is helpful to patients with anorexia nervosa.
| Condition | Intervention |
|---|---|
|
Anorexia Nervosa |
Behavioral: Exposure Therapy + D-Cycloserine Behavioral: Exposure Therapy + Placebo Behavioral: Supportive Psychotherapy |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Food Exposure Therapy in Anorexia Nervosa |
| Enrollment: | 32 |
| Study Start Date: | January 2008 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
EXP-DCS/Exposure-D-cycloserine
Exposure Therapy + D-Cycloserine
|
Behavioral: Exposure Therapy + D-Cycloserine
Exposure therapy with d-cycloserine medication
|
|
EXP-PBO
Exposure Therapy + Placebo
|
Behavioral: Exposure Therapy + Placebo
Exposure therapy with placebo medication
|
|
SP
Supportive psychotherapy
|
Behavioral: Supportive Psychotherapy
Supportive psychotherapy
|
Detailed Description:
This is a research study to determine whether a medication called D-cycloserine (DCS) in combination with a type of psychotherapy called Exposure Therapy is helpful to patients with anorexia nervosa. DCS is approved by the FDA as an antibiotic medication, but has not been approved by the FDA for the treatment of anorexia nervosa. Past studies have found that DCS together with Exposure Therapy can help people with height phobia, social phobia, and obsessive compulsive disorder. Anorexia nervosa often includes phobia-like fears, obsessive thoughts, and compulsive rituals, so the current study aims to determine whether DCS paired with Exposure Therapy can also help people with anorexia nervosa. Anorexia nervosa is a disorder characterized by self-starvation, extreme weight loss, and difficulty maintaining a normal weight. You have been asked to participate in this study because you have been given a diagnosis of anorexia nervosa. In this study you will receive one of three therapies: Exposure Therapy with DCS, Exposure Therapy with placebo (inactive medication), or Treatment as Usual. You will participate in a total of four test meals in a laboratory setting. A total of 70 individuals with anorexia nervosa will participate in this study. Twenty individuals who have never had an eating disorder will participate in one portion of this study.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inpatients receiving treatment for anorexia nervosa
Inclusion Criteria for Patients:
- DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype) on admission
- Subjects will have achieved 90% of ideal body weight (IBW)
- Age 18-45
- Medically stable
- Participation in inpatient treatment
- Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria for Patients:
- Any other current major Axis I disorder, except OCD or MDD (mild)
- On psychotropic medication, including benzodiazepines (At the start of the study, subjects will be free of fluoxetine for 4 weeks, and free of all other medications for a minimum of 2 weeks.)
- History of a seizure disorder
- Abnormal liver function
- Renal insufficiency
- Known hypersensitivity to D-cycloserine
- Pregnant or lactating
- Acute suicidality (suicidality or self injury in the last 3 months)
Inclusion Criteria for Healthy Controls:
- BMI ≥ 19.0 kg/m2
- Age 18-45 years
- Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion Criteria for Healthy Controls:
- Current Major Axis I disorder (including Eating Disorder, Major Depression,Bipolar Disorder, Schizophrenia, Substance Abuse/Dependence) History of an Eating Disorder
- Current use of psychotropic medication or other medication known to affect mood and/or anxiety (e.g. b-agonist inhalers, oral steroids)
- Major medical condition
Contacts and Locations| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Joanna Steinglass, M.D. | CUMC/NYSPI |
More Information
No publications provided by New York State Psychiatric Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00755820 History of Changes |
| Other Study ID Numbers: | 5457 |
| Study First Received: | September 18, 2008 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Anorexia Anorexia Nervosa Signs and Symptoms, Digestive Signs and Symptoms Eating Disorders Mental Disorders Cycloserine Anti-Infective Agents, Urinary Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Renal Agents Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013